TerminatedPhase 2

Melatonin for Renal Protection in Patients Receiving Polymyxin B

Stopped: Due to COVID 19 pandemic social isolation measures, we had to stop recruting hospitalized patients.

Brazil88 participantsStarted 2018-10-01

Plain-language summary

This study has the objective to evaluate the effect in renal function of 30mg of Melatonin versus placebo in patients ≥18 years old treated with polymyxin B. The development of nephrotoxicity will be evaluated by RIFLE(Risk, Injury, Failure, Loss, End stage renal disease) score and KIM-1 urinary biomarker for the first 14 days of polymyxin B therapy.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Treatment with polymyxin B ( a second inclusion will be accepted if the end of the previous treatment was more than 30-days before enrollment)
✓. Agreement with the consent form

Exclusion criteria

✕. Suspension of polymyxin B therapy with \<48hs
✕. Death in \<48hs
✕. Dialysis or Glomerular Filtration Rate (GFR) \<10 ml/min at the beginning of treatment by the Modification in Diet in Renal Disease (MDRD) formula
✕. Lactose intolerance
✕. ICU admission at the beginning of therapy
✕. Previous regular use of Melatonin
✕. Pregnancy
✕. Patients deprived from liberty

What they're measuring

Acute Kidney Injury according to RIFLE criteria

Timeframe: 14 days Renal Failure.

Trial details

NCT IDNCT03725267

SponsorHospital de Clinicas de Porto Alegre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06-15

View on ClinicalTrials.gov More Acute Kidney Injury trials